In my own experience, as I meet with the management teams of smaller companies, I observe that they are considering acquisition post-approval of their assets or even their companies - as the ultimate goal. This spells an essential strategic shift when it comes to managing their intellectual property: to make it easier to enable a simple transfer of assets after acquisition. Making that shift requires a very different approach to managing content when moving from concept to development. Let me break that down into 3 elements for you to consider.

1. Enable a Common Document Strategy

The first principle is convergence of data: the linking of documents from one domain to the other. Instead of existing in silos, documents can be managed in a single repository; for example, the approved version in the regulatory system can be linked directly from the clinical R&D system. Essentially, content associated with the asset starting at discovery stays with it throughout its lifecycle. Now, you have a single authoritative record of truth.

While the sharing of information across domains might require some cultural rethinking, the fact is that intelligent coordination between study startup groups and regulatory can dramatically improve operational efficiency, productivity, accuracy and compliance downstream. And this approach is enabled by what's called a regulatory information management (RIM) system, with a document management solution as a central component. With support from an experienced partner, implementing this common document management foundation is actually a straightforward process - a path many have taken before you.

2. Provide a Full Lifecycle View with What-If Analytics

With a single solution for startup, study management, data management, document publishing, tracking, approval and archiving - your team can quickly locate, verify and employ the information contained. Imagine how this approach can reduce the time from last study completion to submission by eliminating reentry of information. By synchronizing RIM and eTMF, preparing for inspections becomes much easier.

Post-approval, you can respond faster to product changes, compliance concerns or health authority requests. Guided workflow and alerts based upon eTMF changes can expedite reporting of amendments and supplemental changes to regulatory authorities.

This approach enables you to eliminate paper distribution and storage, while allowing rapid access for reviewers and internal stakeholders alike. Executives gain a view of the full lifecycle of a product, encompassing study milestone performance and cycle time, site and subject enrollment planning, site progress, subject recruitment progress, registrations, submissions and drug safety activities. They can use analytics to determine how a potential labeling or product change will affect a registration, as well as the impacts on study conduct.

3. Begin with the End in Mind

Once you have embraced the concept of document sharing throughout your organization, the next clear strategy shift is to move it to the cloud. That's what I mean by enabling simple transfer of assets, including both in-licensing and out-licensing of products. Rather than embedding your intellectual property and associated content in your own IT systems (which requires a full staff to maintain), you can take advantage of a cloud environment. You can leave behind the rigidity of hardware, third-party software and data infrastrucuture, as well as the costs, with a subscription-based solution providing full privacy, security and access control.